NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Bicalutamide Implants (Biolen ) with Radiation Therapy in Patients with Localized Prostate Cancer

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)



Androgen Deprivation Therapy

Recruitment Keyword(s)



Prostate Cancer

Investigational Drug(s)


Investigational Device(s)



Drug: Biolen
Radiation: Radiation

Supporting Site

National Cancer Institute


Many people with prostate cancer receive radiation and anti-androgen drugs. These drugs bind to androgen receptors so that androgens cannot bind to enable cancer growth. Researchers want to test the safety of a new way to deliver anti-androgen drugs.


To test the safety of an implant called Biolen (Registered Trademark), which contains an anti-androgen drug called bicalutamide, in people with prostate cancer who will receive radiation therapy.


People aged 18 and older with prostate cancer.


Participants will be screened with a medical history and physical exam. They will have blood tests. They may have a whole-body bone scan. They may have body imaging scans. They may get a radioactive tracer during their scans.

Participants will repeat some screening tests during the study. They will fill out surveys about their health. They will give urine and semen samples. They may have a biopsy.

Participants will follow their normal treatment for their radiation therapy. But they will not get the standard of care form of anti-androgen therapy that is used for their type of cancer. Nine weeks before treatment starts, they will have the implant procedure. They will be put under anesthesia. They may get a urinary catheter and IV. They may have a trans-rectal ultrasound to guide implant placement. After the procedure, participants will have follow-up visits. They will have a radiation-planning imaging scan.

Participants will have 5 radiation treatments. They will lie on a table while a machine delivers the treatment. The machine will also take x-rays. They will have a follow-up visit after radiation.

After treatment ends, participants will have follow-up visits every 3 months for up to 2 years.

--Back to Top--



- Patients with biopsy proven localized prostate cancer in whom prostate radiation and ADT is appropriate therapy (such as Intermediate Risk localized prostate cancer)

- Patients must have at least 1 MRI detected, biopsy proven prostate cancer tumor.

- Patients diagnosed as one of the following:

-- NCCN intermediate risk prostate cancer, OR

-- NCCN high risk prostate cancer due to Gleason Grade 4 or 5 AND refuses to receive systemic ADT, OR

-- NCCN high risk prostate cancer due to PSA>20 AND refuses to receive systemic ADT.

- Age >18 years.

- ECOG performance status <2.

- Estimated life expectancy >5 years.

- Patients must have adequate organ and marrow function as defined below:

--Leukocytes >=3,000/mcL

--absolute neutrophil count >=1,000/mcL

--platelets >=100,000/mcL

--total bilirubin <1.5x ULN (< 3x ULN for Gilbert s syndrome)

--AST(SGOT)/ALT(SGPT) <=2.5 X institutional upper limit of normal

--Creatinine <= 1.5x ULN OR creatinine clearance >=50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

- The effects of Biolen on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, men must agree to use a highly effective form of contraception or abstinence at the time of study entry and for the duration of study participation (approximately 27 months). Highly effective forms of contraception include.


--Condom with spermicide

--Partner use of one of the following methods:

---Bilateral tubal ligation

---Intrauterine devices (IUDs)

---Hormonal implants (Implanon)

---Combination oral contraceptives

---Progestin-only oral contraceptives that inhibit ovulation

---Progestin-only injections (Depo-Provera)

---Hormonal patches

---Vaginal Ring

Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, the treating physician should be informed immediately.

- Ability of subject to understand and the willingness to sign a written informed consent document.


-Patients who are receiving any other investigational anti-cancer agents. Patients may choose to co-enroll in a separate NIH protocol with 18F-DCFPyL PET/CT.

- NCCN high risk patients eligible for treatment with systemic ADT who do not refuse systemic ADT.

- Patients receiving prior radiotherapy or surgery for prostate cancer.

- Patients receiving prior or ongoing ADT.

- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Biolen or other agents used in study.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

- Patients in whom pelvic nodal irradiation is planned.

- Evidence of tumor spread beyond the prostate (definite extra-prostatic extension, lymph nodes, metastases).

- Imaging evidence or clinical evidence of active prostate inflammation.

- Study participant unwilling or unable to undergo MRI, including patients with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.

- Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images.

- Use of 5 alpha reductase inhibitors (e.g. Finasteride or Dutasteride) within 3 months of screening.

- Prostate volume more than 100 cc at prior MRI imaging.

- I-PSS score >= 20.

- History of bleeding diathesis or currently on anti-coagulation therapy that cannot be safely discontinued for implant procedure.

- Any condition that, in the opinion of the Principal Investigator, which would impair the patient s ability to comply with study procedures.

- Contraindications to radiation or SBRT (such as active lupus or scleroderma, prior pelvic radiation, inflammatory bowel disease)

--Back to Top--


Not Provided

--Back to Top--


Principal Investigator

Referral Contact

For more information:

Deborah E. Citrin, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM B2-3532
(240) 760-6206

Debbie Nathan, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 2-1730
10 Center Drive
Bethesda, Maryland 20892
(301) 451-8968

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


--Back to Top--